Referenznummer: ××××/××××××××××××× Startdatum: asap Projektdauer: 6 MM+ Ort: North Rhine-Westphalia
Act as biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs
Participate in the protocol summary development
Give input into the study design, efficacy and safety parameters and the planned statistical analyses
Perform the sample size calculations and participate in protocol development if this is not delegated to an external partner biostatistician
Review and approve the protocol prepared by the external partner biostatistician
Respond to the request for the randomization schedule and interact appropriately with the IXRS vendor if this is not delegated to an external partner biostatistician
Review data management related documents
Evaluate the quality of the database if this is not delegated to an external partner biostatistician
Author the Statistical Analysis Plan (SAP) or reviews and approve the SAP if prepared by an external partner biostatistician
Review the clinical study report, provide input on interpretation of results by attending the Results Interpretation Meeting (RIM) and understand the regulatory requirements related to design and analysis of studies
Ph.D or Master´s degree in biostatistics or related discipline
Deep knowledge in biostatistics within the biotechnology or pharmaceutical industry, including CROs
Experience in all phases of clinical studies, focused on Phase II - III
Sound knowledge of ICH guidelines and general regulatory requirements
Good knowledge of statistical methodology
Home office possibility
Über Hays: With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Einsatzort: North Rhine-Westphalia
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